Blood Sample Collection Study for Pharmacogenomic Characterization of Participants That Previously Received Namilumab in M1-1188-002-EM (PRIORA, [NCT01317797]) Study

Phase 1

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Other: No Intervention

• Registration Number: NCT02528786
• Lead Sponsor: Takeda

Brief Summary

The purpose of this study is to obtain blood samples from up to 14 participants who previously received namilumab in the previous study M1-1188-002-EM (PRIORA, \[NCT01317797\]) to correlate genetic markers with clinical outcomes.

Detailed Description

Participants who received treatment with namilumab in the previous study M1-1188-002-EM (PRIORA \[NCT01317797\]) will have two whole blood samples (3 mL each) collected to correlate genetic markers with namilumab treatment responses as determined in the previous study.

The study will enroll approximately 14 participants who received namilumab in the previous study.

• No intervention is administered in this study.

This trial will be conducted in Bulgaria, Spain and The Netherlands. The overall time to participate in this study is 1 day.

Study Timeline

• Study First Submitted: 2015-08-13
• Study First Submitted QC: 2015-08-18
• Study First Posted: 2015-08-19
• Study Start: 2015-11-19
• Primary Completion: 2016-04-05
• Study Completion: 2016-04-05
• Results First Submitted: 2017-03-24
• Status Verified: 2017-05
• Results First Submitted QC: 2017-05-26
• Last Update Submitted: 2017-05-26
• Results First Posted: 2018-01-02
• Last Update Posted: 2018-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

1. The participant (or, when applicable, the participant's legally acceptable representative) voluntarily signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.

Read More

Exclusion Criteria

1. Did not receive namilumab during the PRIORA study (A phase Ib double-blind, placebo controlled, randomized, dose-escalating study).
2. Participants without any response time point recorded 4-week after the last dose of namilumab and beyond this time point
3. Participants who were excluded from post-hoc analysis due to protocol violations during the previous PRIORA study.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All Participants	No Intervention	Participants who received namilumab previously in M1-1188-002-EM (PRIORA, \[NCT01317797\]) will have blood samples collected on Day 1.

Primary Outcome Measures

Name	Time	Method
Number of Participants in Each Cluster	Baseline	Clusters are described by an ellipse whose major and minor axes are the standard deviations in the x and y directions of the component points, which are rotated so that their covariance is equal to zero. The clusters were based upon the algorithms in which each data-point is assigned to one of four clusters: 1, 2, 3, or 4, representing no-target (negative controls \[NTCs\]), homozygotes one (XX), homozygotes two (YY), and heterozygotes (XY), respectively. Based on the calculated genetic composite scores from 8-single-nucleotide polymorphism (SNP)-based algorithm, participants were segregated into clusters.